31
48 Feed (4.1) Production of refined soya (bean) oil (4.2) Production of soy fatty acid distillates (4.3) Production of soy acid oils (4.4) Production of soy deo- distillates (4) Refining Filter aids Soap stocks Used bleaching earth (3) Crushing of soya (beans) Hulls (3.2) Production of crude lecithins (gums) (3.1) Production of crude oil (3.3) Production of soya (bean) meal Soy acid oils Refined soya (bean) oil Soya (bean) hulls (A) Transport EU FEED INDUSTRY INSIDE EU (B) Transport Crude lecithins (3.4) Separation of soya (bean) hulls Crude degummed soya (bean) oil Soya (bean) meal (B) Transport Blending (C) Storage (B) Transport (C) Storage (B) Transport (C) Storage (Semi batch refining) Soy deo distillates Soy fatty acid distillates (Semi batch refining) (D) Transport by ocean going vessel OUTSIDE EU Flow chart of the production chain of soya (bean) meal and oil products for feed application in the EU Crushing of soya (beans) Hulls Production of crude lecithins (gums) Production of crude oil Production of soya (bean) meal (1) Cultivation of soya (beans) Soya (beans) Dried soya (beans) (A) Transport Storage (2) Drying at primary production Crude lecithins Separation of soya (bean) hulls Characters between brackets refer to those on the following sheets Production of refined soya (bean) oil Production of soy fatty acid distillates Production of soy acid oils Production of soy deo- distillates Refining Soy deo distillates Soy fatty acid distillates Soya acid oils Refined soya (bean) oil Used bleaching earth Filter aids Soap stocks (B)Transport Storage Crude degummed soya (bean)oil Soya (bean) meal Soya (bean) hulls (B) Transport (A) Transport Storage (D) Transport by ocean going vessel

Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

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Page 1: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

48

Feed Risk assessment of the chain of soya (bean) meal and oil products

(4.1)

Productionof refined

soya (bean) oil

(4.2)

Production of soy fatty

acid distillates

(4.3)

Production of soy acid

oils

(4.4)

Production of soy deo- distillates

(4) Refining

Filter

aids

Soap

stocks Used bleaching

earth

(3) Crushing of soya (beans)

Hulls

(3.2) Production of crude lecithins (gums)

(3.1) Production of crude oil

(3.3) Production of soya (bean) meal

Soy acid oils

Refined soya

(bean) oil

Soya (bean) hulls

(A) Transport EU FEED INDUSTRY

INSIDE EU

(B) Transport

Crude lecithins

(3.4) Separation of soya (bean) hulls Crude degummed

soya (bean) oil

Soya (bean) meal

(B) Transport

Blending (C) Storage

(B) Transport

(C) Storage

(B) Transport (C) Storage

(Sem

i

batc

h

refin

ing)

Soy deo

distillates

Soy fatty acid

distillates

(Sem

i bat

ch

refin

ing)

(D) Transport by

ocean going

vessel

OUTSIDE EU

Flow chart of the production chain of soya (bean) meal and oil products for feed application in the EU

Crushing of soya (beans)

Hulls Production of crude lecithins (gums)

Production of crude oil

Production of soya (bean) meal

(1) Cultivation of soya (beans)

Soya (beans)

Dried soya (beans)

(A) Transport Storage

(2) Drying at primary production

Crude lecithins

Separation of soya (bean) hulls

Characters between brackets refer to those on the following sheets

Production of refined soya

(bean) oil

Production of soy fatty acid

distillates

Production of soy acid

oils

Production of soy deo- distillates

Refining Soy deo distillates

Soy fatty acid

distillates

Soya acid oils

Refined soya

(bean) oil

Used bleaching earth Filter aids

Soap stocks

(B)Transport

Storage

Crude degummed

soya (bean)oil

Soya (bean) meal

distillates Soya (bean) hulls

(B) Transport

(A) Transport Storage

(D) Transport by ocean

going vessel

Page 2: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

49

Feed Risk assessment of the chain of soya (bean) meal and oil products

6. Risk assessment of the chain of soybean meal and oil products

1. Cultivation of soya (beans)*

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C The countries of export of soya (beans)

(USA, Brazil, Argentina and Paraguay)

work with positive lists for the use of

pesticides during cultivation which, for

some substances, may conflict with

European pesticide residue legislation.

Regular monitoring of pesticides on soya

(beans) shows that residue levels remain

within legal limits.

EC Regulation 396/2005

prohibits putting into

circulation commodities that

do not comply with the MRLs

set in the annexes. EC

Regulation No. 178/2006

establishes Annex I that lists

the food and feed products for

which pesticide residue limits

apply. Regulation 149/2008

establishes Annexes II, III and

IV that sets the MRLs for the

products listed in Annex I.

Non-EU-authorised GMOs B Different pace of approval of new GMOs

between EU and third countries from

which oilseeds are imported. Risk of

traces of non-EU-authorised GMOs

ending up in EU imported oilseeds.

This is an issue of legal

compliance, rather than one

on food safety.

Phytotoxins C Soya (beans) may contain weeds. Directive 2002/32/EC limits

the maximum content of toxic

weed seeds.

Visual inspection of soya

(beans) is recommended as a

control measure.

* Assessment of risks outside the EU is out of the scope of this document. See Methodology document paragraph 2.3 for more information.

Page 3: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

50

Feed Risk assessment of the chain of soya (bean) meal and oil products

2. Drying of soya (beans) at primary production*

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR CONTRACT

TERMS

CONTROL MEASURE REMARKS

Contaminants caused by

drying

- dioxin C Burning of waste may result in

dioxin formation. Up to now

the crushers have found

dioxin levels in crude soya

(bean) oil to be lower than

detection limit.

Code of Practice for the

prevention and reduction of

dioxin and dioxin-like PCB

contamination in foods and

feeds (Codex CAC/RCP 62-

2006).

Good Manufacturing Practices recommend using fuels which are not generating dioxins and dioxin-like compounds and other harmful contaminants.

In case of direct heating, proper burners should be used. Monitoring is regarded necessary to ensure that drying or heating processes do not result in elevated levels of dioxins and dioxin-like PCBs. No use of waste products as a fuel for direct drying.

Feed materials derived from

soya (beans) have to comply with the

limits for dioxin and dioxin-like PCBs

of the Directive 2002/32/EC.

* Assessment of risks outside the EU is out of the scope of this document. See Methodology document, paragraph 2.3 for more information.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

51

Feed Risk assessment of the chain of soya (bean) meal and oil products

Utilities: soya (beans) crushing, oil refining and processing

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Hydraulic oils or lubricants

from equipment

C Low High 3 Hydraulic oils and lubricants may contain

toxic compounds.

The prerequisite programme

should assure that the

contamination of product with

non-food grade hydraulic oils

or lubricants is avoided and

that the risk of contamination

of the product with food grade

hydraulic oils and lubricants is

minimised. The prerequisite

programme could involve

recording of the quantities

used.

Contaminants in water

such as PFOS and PFOA

C Low Medium 2 Water is used in the crushing and refining

process.

For manufacture of feed,

according to Regulation

183/2005/EC water used

shall be of suitable quality.

Cleaning agents and boiler

chemicals

C Medium Medium 3 Cleaning agents and steam (using boiler

chemicals) come into contact with the

product.

Cleaning agents used in the

production system should be

flushed. Cleaning agents and

boiler chemicals must be

suitable for use in the food

industry.

Thermal heating fluids

(THF) from equipment

C Medium High 4 THF may still be used by non-FEDIOL

members.

According to the FEDIOL

Code of Practice on the

Heating of Edible Oils during

Processing, the use of THF is

not allowed.

Use hot water or steam

heating. Otherwise, a control

measure should assure that

the contamination of product

with thermal heating fluids is

avoided.

Page 5: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

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Feed Risk assessment of the chain of soya (bean) meal and oil products

3. Crushing of soya (beans)

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Toxins from pest control

materials

C Low High 3 Poisoned grain from open boxes could

end up in the food chain.

A pest control programme

must be applied that is

suitable for use in the food

chain.

Toxic compounds from

hexane such as benzene

C Low High 3 Industrial hexane may contain toxic

compounds.

Directive 2009/32/EC sets

purity criteria for the use of

hexane during the crush of

oilseeds.

Food grade hexane must be

used.

Foreign material like glass,

wood, metals, etc.

P Medium Medium 3 Foreign material may be present. A system should be in place

that removes foreign material.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

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Feed Risk assessment of the chain of soya (bean) meal and oil products

3.1 Production of crude oil

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Contaminants from filter

aids

C Low High 3 The crude oil can potentially wash

contaminants out of the filter aid.

Use of filter aids that are

suitable for the food industry.

Mineral oils from a failing

recovery system

C Medium Medium 3 Food grade low-medium viscosity mineral

oils are used for hexane recovery. It is in

the interest of the crusher to recover as

much hexane as possible, and to thus

maintain the recovery system well.

Mineral oil of the recovery

system must be of food grade

quality. The prerequisite

programme should assure

that the contamination of

product with non-food grade

oils is avoided and that the

risk of contamination of the

product with food grade oils is

minimised. The prerequisite

programme could involve

recording of the quantities

used.

The Dutch GMP-limit for

C (10-40) in oils is 400

mg/kg.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low* Medium 2 Regular monitoring of pesticide residues

on soya (beans) shows that residue levels

remain within legal limits.

Regulation 396/2005 sets

limits for residues of

pesticides. This regulation

allows using a processing/

concentration factor for

pesticides into processed

products, providing food

safety is assured.

The FEDIOL position

(11SAF181) concludes that

based on the average oil

content in soybeans ranging

from 18%-21%, a processing

factor of 5 should be used to

*Certain origins of

soybeans can have a

medium chance of

exceeding the MRL for

particular pesticide

residues.

Page 7: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

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Feed Risk assessment of the chain of soya (bean) meal and oil products

establish the MRL in soybean

oil.

Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C very low High 2 Some of the banned pesticides may be

present in the environment. The chance of

finding them in crude soya (bean) oil,

however, is very low. The use of

endosulfan is allowed on soya (beans).

Monitoring data show that its residue in

crude oil remains within the legal limit.

Directive 2002/32/EC sets

limits for a number of

pesticides residues in feeding

stuff.

Hexane that resides in the

crude oil after recovery

C High little 3 After hexane extraction of the oil and

subsequent hexane recovery from the oil,

traces of hexane will reside in the crude

oil.

Feed Marketing Regulation

767/2009 stipulates that feed

materials shall be free from

chemical impurities resulting

from the manufacturing

process and from processing

aids, unless a maximum

content is fixed in the

Catalogue. The Catalogue of

Feed Materials, Regulation

68/2013 introduces a

threshold for the setting of

max contents for these

chemical impurities of 0.1%

(1000 ppm).

Toxicological

assessments show that

crude soya oil with

hexane levels of up to

1000 ppm is feed safe.

FOSFA has a flash point

limit at 121 ̊C, which is

related to transport and

storage safety.

Page 8: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

55

Feed Risk assessment of the chain of soya (bean) meal and oil products

3.2 Production of crude lecithins

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Mineral oils from a failing

recovery system

C Medium Medium 3 Food grade low-medium viscosity mineral

oils are used for hexane recovery. It is in

the interest of the crusher to recover as

much hexane as possible, and to thus

maintain the recovery system well.

Mineral oil of the recovery

system must be of food grade

quality. The prerequisite

programme should assure

that the contamination of

product with non-food grade

oils is avoided and that the

risk of contamination of the

product with food grade oils is

minimised. The prerequisite

programme could involve

recording of the quantities

used.

The Dutch GMP-limit for

C (10-40) in oils is 400

mg/kg.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low* Medium 2 Regular monitoring of pesticide residues

on soya (beans) shows that residue levels

may exceed legal limits.

Regulation 396/2005 sets

limits for residues of

pesticides. This regulation

allows using a processing/

concentration factor for

pesticides into processed

products, providing food

safety is assured.

Check incoming soybeans or

the crude lecithins. In case of

a pesticide residue level

exceeding the limit, a feed

safety assessment should be

carried out.

*Certain origins of

soybeans can have a

medium chance of

exceeding the MRL for

particular pesticide

residues.

Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C very low High 2 Some of the banned pesticides may be

present in the environment. The chance of

finding them in crude soya (bean) oil,

however, is very low. The use of

endosulfan is allowed on soya (beans).

Monitoring data show that its residue in

crude oil remains within the legal limit.

Directive 2002/32/EC sets

limits for a number of

pesticides residues in feeding

stuff.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

56

Feed Risk assessment of the chain of soya (bean) meal and oil products

Hexane that resides in the

crude lecithins after

recovery

C High little 3 After hexane extraction of the oil and

subsequent hexane recovery from the oil,

traces of hexane will reside in the crude

oil.

Feed Marketing Regulation

767/2009 stipulates that feed

materials shall be free from

chemical impurities resulting

from the manufacturing

process and from processing

aids, unless a maximum

content is fixed in the

Catalogue. The Catalogue of

Feed Materials, Regulation

68/2013 introduces a

threshold for the setting of

max contents for these

chemical impurities of 0.1%

(1000 ppm).

Toxicological

assessments show that

feed materials with

hexane levels of up to

1000 ppm are feed safe.

FOSFA has a flash point

limit at 121 ̊C, which is

related to transport and

storage safety.

Pathogens B Low Medium 2 Microbiological growth as a result of

condensation of water evaporated from

the wet gums.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

57

Feed Risk assessment of the chain of soya (bean) meal and oil products

3.3 Production of soya (bean) expeller and meal

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Dioxin from anti-caking

agent

C Low High 3 Anti-caking agent is of mineral origin and

may contain dioxin by nature. Dioxin is

toxic to humans and animals.

Regulation 2439/1999/EC

sets quality criteria for anti-

caking agents.

Purchase anti-caking agent of

feed grade quality.

Salmonella B High High 4 Salmonella is the major hazard for

microbiological contamination of feed.

Salmonella are widespread in the

environment and each link in the food

chain, from the producers up to and

including the consumers has a role to play

in reducing the risk of Salmonella harming

animals or humans. FEDIOL together with

three other associations representing the

suppliers and consumers of feed, ie

FEFAC, COCERAL and COPA-COGECA

have accepted responsibility for issuing

guidance for industry to help it control

Salmonella and have published the

“Common principles for the management

of the Salmonella risk in the feed chain” in

June 2011. The European Guide to good

practice for the industrial manufacture of

safe feed materials has been amended so

as to comply with these principles.

FEDIOL, FEFAC, COCERAL,

COPA-COGECA Common

principles for the

management of the

Salmonella risk in the feed

chain.

The operator’s PRP

programme is to cover the

following measures:

a) Preserving feed materials

from contamination during

processing and storage eg by

closed systems, hygiene

practices, or by separating the

premises into hygienic zones

as appropriate.

b) Applying time and

temperature control on the

Desolventiser Toaster (DT).

c) Apply moisture control of

the meals/expellers

If the monitoring system

indicates that Salmonella is

found in the finished feed

material, the following actions

shall be considered:

o Carry out serotyping and traceability to

The operator shall

introduce line monitoring

with samples to be taken

from the whole line, from

where the product leaves

the DT, from when it

enters the storage silo up

to and including the load

out area.

The operator is to set

realistic targets for

reduction of the

incidence of Salmonella

contamination of his

meals/expellers basis

historic data.

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Feed Risk assessment of the chain of soya (bean) meal and oil products

identify the source of contamination; o Review processing conditions and relevant pre-requisite programs o Additional cleaning of storage and vehicles (where appropriate); o Additional cleaning of plant and equipment; o Review previous monitoring results o Consider additional training or changes in process or procedures o Applying chemical treatment with the aim to reduce Salmonella to acceptable levels.

Dioxin from used bleaching

earth

C Low High 3 Bleaching clay is of mineral origin and

may contain dioxin by nature. Dioxin is

toxic to humans and animals.

Directive 2002/32/EC limits

the dioxin content in feed

material of vegetable origin to

0.75 ng/kg (WHO-PCDD/F-

TEQ) and limits the sum of

dioxin and dioxin-like PCBs to

1,5 ng/kg (WHO-PCDD/F-

PCB-TEQ).

FEDIOL has developed a

Code of Practice on the

purchase conditions of fresh

bleaching earth for oil refining,

which includes a maximum

limit for dioxin and dioxin-like

PCBs of 1,5 ng/kg (WHO-

PCDD/F-PCB-TEQ) as

upperbound value.

Purchase fresh bleaching

earth from suppliers that fulfil

the FEDIOL specifications as

listed in the FEDIOL Code of

Practice on the purchase

conditions of fresh bleaching

earth for oil refining.

The risk only applies to

integrated crushing and

refining plants.

Hexane residue C High little 3 Hexane residue is present in oilseed

meals.

Feed Marketing Regulation

767/2009 stipulates that feed

materials shall be free from

Toxicological

assessments show that

oilseed meals with

Page 12: Flow chart of the production chain of soya (bean) meal and oil … consolidated.pdf · 51 Feed Risk assessment of the chain of soya (bean) meal and oil products Utilities: soya (beans)

EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

59

Feed Risk assessment of the chain of soya (bean) meal and oil products

chemical impurities resulting

from the manufacturing

process and from processing

aids, unless a maximum

content is fixed in the

Catalogue. The Catalogue of

Feed Materials, Regulation

68/2013 introduces a

threshold for the setting of

max contents for these

chemical impurities of 0.1%

(1000 ppm).

hexane levels of up to

1000 ppm are feed safe.

Germany has contractual

specifications of max 300

ppm hexane in soybean

meal for explosion

prevention during barge

transport.

Cadmium C Low Medium 2 Depending on origin soybeans can contain

elevated levels of Cd as a result of

fertiliser basis Cd contaminated

phosphorus.

This risk is applying to

certain geographical

origins.

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Feed Risk assessment of the chain of soya (bean) meal and oil products

3.4 Separation of soya (bean) hulls

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Salmonella B High High 4 Salmonella is the major hazard for

microbiological contamination of feed.

Salmonella are widespread in the

environment and each link in the food

chain, from the producers up to and

including the consumers has a role to play

in reducing the risk of Salmonella harming

animals or humans. FEDIOL together with

three other associations representing the

suppliers and consumers of feed, ie

FEFAC, COCERAL and COPA-COGECA

have taken their responsibility and have

published the “Common principles for the

management of the Salmonella risk in the

feed chain” in June 2011. The European

Guide to good practice for the industrial

manufacture of safe feed materials has

been amended so as to comply with these

principles.

FEDIOL, FEFAC, COCERAL,

COPA-COGECA Common

principles for the

management of the

Salmonella risk in the feed

chain.

.

The operator’s PRP

programme is to cover the

following measures:

a) Preserving feed materials

from contamination during

processing and storage eg by

closed systems, hygiene

practices, or by separating the

premises into hygienic zones

as appropriate.

b) Apply moisture control

If the monitoring system

indicates that Salmonella is

found in the finished feed

material, the following actions

shall be considered:

o Carry out serotyping and traceability to identify the source of contamination; o Review processing conditions and relevant pre-requisite programs o Additional cleaning of storage and vehicles (where appropriate); o Additional cleaning of plant and equipment;

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Feed Risk assessment of the chain of soya (bean) meal and oil products

o Review previous monitoring results o Consider additional training or changes in process or procedures o Applying chemical treatment with the aim to reduce Salmonella to acceptable levels.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low* Medium 2 Regular monitoring of pesticide residues

on soybeans shows that residue levels

remain within legal limits.

MRL policy in third countries differs from

EU MRL policy.

EC Regulation No. 396/2005 sets

limits for residues of pesticides.

FEDIOL contract for purchasing

sun seeds form the Black Sea

area (contains a clause on

compliance with EU MRL

legislation).

*Certain origins of

soybeans can have a

medium chance of

exceeding the MRL for

particular pesticide

residues.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

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Feed Risk assessment of the chain of soya (bean) meal and oil products

4. Refining

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Contaminants in

Processing aids

(alkali solution, acids) such

as mercury in caustic soda.

C Low High 3 Processing aids come into contact with the

product.

Processing aids that directly

come into contact with the oil

must be for food use or of

food grade quality.

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4.1 Production of refined soya (bean) oil

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY STANDARDS AND/OR

CONTRACT TERMS CONTROL MEASURE REMARKS

Dioxin and dioxin-like PCBs C Low High 3 A potential source of dioxin contamination

for the oil is drying of soybeans and

bleaching earth. However, the dosage

level of bleaching earth during refining is

only 1-3%. Dioxin partly evaporates during

distillation.

Directive 2002/32/EC limits the dioxin content

in feed material of vegetable origin to 0.75

ng/kg (WHO-PCDD/F-TEQ) and limits the

sum of dioxin and dioxin-like PCBs to

1,5 ng/kg (WHO-PCDD/F-PCB-TEQ).

FEDIOL has developed a Code of Practice on

the purchase conditions of fresh bleaching

earth for oil refining, which includes a

maximum limit for dioxin and dioxin-like PCBs

of 1,5 ng/kg (WHO-PCDD/F-PCB-TEQ) as

upperbound value.

Purchase fresh

bleaching earth from

suppliers that fulfil the

FEDIOL specifications

as listed in the FEDIOL

Code of Practice on the

purchase conditions of

fresh bleaching earth

for oil refining.

CB: If during

the revision of

the FBE code,

that code is

only going

apply for

integrated

crushing, and

hence not for

stand-alone

refining, then

the reference to

bleaching earth

being a source

for dioxin

contamination

should be

deleted from

the justification

column.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low* Medium 2 Regular monitoring of pesticide residues

on soya (beans) shows that residue levels

may exceed legal limits. However, the

experience is that pesticide residues are

removed during refining.

Regulation 396/2005 sets limits for residues

of pesticides. This regulation allows using a

processing/concentration factor for

pesticides into processed products, providing

feed safety is assured.

The FEDIOL position (11SAF181) concludes

that based on the average oil content in

soybeans ranging from 18%-21%, a

processing factor of 5 should be used to

establish the MRL in soybean oil.

*Certain origins

of soybeans

can have a

medium chance

of exceeding

the MRL for

particular

pesticide

residues.

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Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C very Low High 2 Some of the banned pesticides may be

present in the environment. The chance of

finding them in crude soya (bean) oil,

however, is very low. The use of

endosulfan is allowed on soya (beans).

Monitoring data show that its residue in

crude oil remains within the legal limit.

Directive 2002/32/EC sets limits for a number

of pesticides residues in feeding stuff.

Foreign materials like glass,

wood, metals, etc.

P Medium Medium 3 Foreign materials may be present. Apply hygienic

practices (eg closed

systems). Filter before

loading.

4.2 Physical refining: production of soy fatty acid distillates

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY STANDARDS AND/OR

CONTRACT TERMS CONTROL MEASURE REMARKS

Dioxin C Low High 3 A potential source of dioxin contamination

during refining of the oil is bleaching earth.

However, the dosage level of bleaching

earth during refining is only 1-3%.

Directive 2002/32/EC limits the dioxin content

in feed material of vegetable origin to 0.75

ng/kg (WHO-PCDD/F-TEQ) and limits the

sum of dioxin and dioxin-like PCBs to

1,5 ng/kg (WHO-PCDD/F-PCB-TEQ).

Products intended for animal feed containing

a level of undesirable substance that exceeds

the legal limit may not be mixed for dilution

purposes with the same, or other, products

Purchase fresh

bleaching earth from

suppliers that fulfil the

FEDIOL specifications

as listed in the FEDIOL

Code of Practice on the

purchase conditions of

fresh bleaching earth

for oil refining.

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intended for animal feed (Directive

2002/32/EC).

According to Regulation 225/2012 amending

the Feed Hygiene Regulation 183/2005 100%

of the batches of fatty acid distillates for feed

shall be tested on the sum of dioxins and

dioxin-like PCBs.

FEDIOL has developed a Code of Practice on

the purchase conditions of fresh bleaching

earth for oil refining, which includes a

maximum limit for dioxin and dioxin-like PCBs

of 1,5 ng/kg (WHO-PCDD/F-PCB-TEQ) as

upperbound value.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low* Medium 2 Regular monitoring of pesticide residues

on soya (beans) shows that residue levels

may exceed legal limits. During refining

pesticide residues move from the oil to the

fatty acid distillate.

Regulation 396/2005 sets limits for residues

of pesticides. This regulation allows to use a

processing/concentration factor for

pesticides into processed products, providing

feed safety is assured.

Check incoming

soybeans or the fatty

acid distillates. In case

of a pesticide residue

level exceeding the

limit, a feed safety

assessment should be

carried out.

*Certain origins

of soybeans

can have a

medium chance

of exceeding

the MRL for

particular

pesticide

residues.

Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C Low High 3 Some of the banned pesticides may be

present in the environment. The chance of

finding them in crude soya (bean) oil,

however, is very low. The use of

endosulfan is allowed on soya (beans).

Monitoring data show that its residue in

crude oil remains within the legal limit.

Directive 2002/32/EC sets limits for a number

of pesticides residues in feeding stuff.

Non-complying product

should not be applied to

feeding stuff.

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4.3 Chemical refining: production of soy soap stocks and soy acid oils free from deodistillates

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY STANDARDS AND/OR

CONTRACT TERMS CONTROL MEASURE REMARKS

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Low Medium 2 Regular monitoring of pesticide residues

on soya (beans) shows that residue levels

remain may exceed limits. Level of

pesticide residues in acid oil will mirror

that in crude oil.

Regulation 396/2005 sets limits for residues

of pesticides. This regulation allows using a

processing/concentration factor for authorised

pesticides into processed products, providing

feed safety is assured.

Check incoming beans

or the soap stock and

acid oil. In case of a

pesticide residue level

exceeding the limit, a

feed safety assessment

should be carried out.

*Certain origins

of soybeans

can have a

medium chance

of exceeding

the MRL for

particular

pesticide

residues.

Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C very low High 2 Some of the banned pesticides may be

present in the environment. The chance of

finding them in crude soya (bean) oil,

however, is very low. The use of

endosulfan is allowed on soya (beans).

Monitoring data show that its residue in

crude oil remains within the legal limit.

Directive 2002/32/EC sets limits for a number

of pesticides residues in feeding stuff.

Dioxin C Very low High 2 The FEDIOL factsheet on crushing and

refining in relation to soap stock

production (Ref 12SAF183) indicates that

the level of oil soluble contaminants in

soap stocks mirrors that of crude oils.

According to Regulation 225/2012 amending

the Feed Hygiene Regulation 183/2005 100%

of the batches of soap stocks and acid oils for

feed shall be tested on the sum of dioxins

and dioxin-like PCBs.

In integrated

crushing and

refining plants,

soap stocks can

therefore be

safely put back

on the meal.

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4.4 Chemical refining: production of soy deodistillates

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY STANDARDS AND/OR

CONTRACT TERMS CONTROL MEASURE REMARKS

Dioxin C Medium High 4 A potential source of dioxin

contamination during refining of the oil

is bleaching earth. During chemical

refining, dioxins concentrate into the

deodistillates.

Directive 2002/32/EC limits the dioxin content in

feed material of vegetable origin to 0.75 ng/kg

(WHO-PCDD/F-TEQ) and limits the sum of dioxin

and dioxin-like PCBs to 1,5 ng/kg (WHO-PCDD/F-

PCB-TEQ).

According to Regulation 225/2012 amending the

Feed Hygiene Regulation 183/2005 100% of the

batches of deodistillates for feed shall be tested on

the sum of dioxins and dioxin-like PCBs.

Products intended for animal feed containing a level

of undesirable substance that exceeds the legal

limit may not be mixed for dilution purposes with the

same, or other, products intended for animal feed

(Directive 2002/32/EC).

FEDIOL has developed a Code of Practice on the

purchase conditions of fresh bleaching earth for oil

refining, which includes a maximum limit for dioxin

and dioxin-like PCBs of 1,5 ng/kg (WHO-PCDD/F-

PCB-TEQ) as upperbound value.

Deodistillates from chemical

refining are forbidden for use

in feed unless they have been

treated so as to ensure that

dioxin levels are matching

limits of the Undesirable

Substances Directive 2002/32

(see also the FEDIOL

factsheet on treated

deodistillates for use in feed,

Ref 12SAF196).

Fatty products obtained from

batch refining processes

combining physical and

chemical refining steps in one

and the same equipment may

be used for feed purposes,

provided that there is

analytical proof showing that

limits for dioxin and pesticide

residues are respected.

Purchase fresh bleaching

earth from suppliers that fulfil

the FEDIOL specifications as

listed in the FEDIOL Code of

Practice on the purchase

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conditions of fresh bleaching

earth for oil refining.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C High Medium 4 Regular monitoring of pesticide

residues on soya (beans) shows that

residue levels may exceed legal

limits.During chemical refining,

pesticide residues concentrate into the

deodistillates.

Regulation 396/2005 sets limits for residues of

pesticides. This regulation allows using a transfer

factor for authorised pesticides into processed

products, providing feed safety is assured.

Check incoming soybeans or

deodistillate. In case of a

pesticide residue level

exceeding the limit, a feed

safety assessment should be

carried out.

Pesticides residues as

listed in EU Directive

2002/32 for undesirable

substances in feeding stuff

C Medium High 4 Some of the banned pesticides may be

present in the environment. The

chance of finding them in crude soya

(bean) oil, however, is very low. During

refining, endosulfan may partly end up

in the distillate.

Directive 2002/32/EC sets limits for a number of

pesticides residues in feeding stuff.

See above under “general”.

Deodistillates from chemical

refining are forbidden for use

in feed unless they

have been treated so as to

ensure that pesticide residue

levels levels are matching

limits of the Undesirable

Substances Directive 2002/32

(see also the FEDIOL

factsheet on treated

deodistillates for use in feed,

Ref 12SAF196)..

Mineral oil C Medium Medium 3 Mineral oil used as anti dusting agent

will concentrate in the deodistillate

Check incoming soybeans or

deodistillate.

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5. Hydrogenation of soybean oil

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

nickel C Low High 3 Nickel is used as a catalyst with

hydrogenation (hardening) of oil.

Processing aids that directly

come into contact with the oil

must be for food use or of

food grade quality.

Filter the hardened oil.

The nickel content of

hardened oils from

FEDIOL members is well

below 20 ppm.

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A. Storage and transport of soybeans and soybean meal and hulls

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR CONTRACT

TERMS

CONTROL MEASURE REMARKS

Toxins from pest control

materials

C Low High 3 Poisoned grain from open boxes could end up in

the food chain.

A pest control programme

must be applied that is

suitable for use in the food

chain.

Pesticide residues above

the MRL, i.e. residues of

herbicides, insecticides,

fungicides or rodenticides

above the MRL.

C Medium Medium 3 Post-harvest use of pesticides on oilseeds is

critical due to the limited time that is available for

the pesticides to break down. The countries of

export of oilseeds work with positive lists for the

use of pesticides which, for some substances,

may conflict with European legislation,

particularly in the case of soft seeds such as

those of sunflowers.

Regulation 396/2005 prohibits

putting into circulation

commodities that do not comply

with the MRLs set in the annex of

this regulation.

Transport and storage

companies must use

pesticides correctly and

document this. Otherwise

they must verify that the

levels of the residues of

the pesticides used during

transport and storage

comply with EU legislation.

Contamination by the

previous cargo during the

transport by farm cart, truck

or barge or ocean going

vessel

C Low High 3 Transport of oilseeds and oilseed meals usually

does not take place in means of transport that

are dedicated to the transport of food or feed.

Transport companies must

clean farm carts, trucks,

barges and ocean-going-

vessels before loading.

Inspection on cleanliness

before loading.

Contamination by the

previous cargo during

storage

C Low High 3 Oilseeds and oilseed meals may be

contaminated with mycotoxin containing

previous loads.

Storage companies must

clean sites before use and

must inspect them on

cleanliness before use.

Anti dusting agent on soya

(beans)

C Medium Medium 3 For dust prevention, the USA allows the

spraying of white oils (paraffins) on soya (beans)

at levels of up to 200 ppm. In South America

soya (bean) oil is used.

Check incoming soybeans

from the USA.

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Adulteration with melamine C Low Medium 2 Analytically, melamine mimics proteins Regulation 2002/32 sets a limit of

2.5 mg/kg for melamine in feed

materials.

New

B.

Transport of soybean oil and derived products for feed application by

tank car, rail tank, barge or coaster (excluding ocean going vessel).

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Contamination by previous

cargo

- Tank cars, rail tanks and barges

C Medium High 4 Tank cars and barges may have been

used for non food or non feed

compatible products such as

petrochemicals.

Tank cars and barges that are

not dedicated to the transport

of foodstuff or feeding stuff

should have undergone a

validated cleaning procedure.

- Tank cars, tank containers,

rail tanks and barges

following EU standards for the

transport of food stuffs

C Low High 3 Transport of most of the vegetable oils

is by means of transport that is

dedicated to food stuffs.

The Food Hygiene

Regulation No. EC/852/2004

requires the transport of liquid

food stuffs by tank cars, rail

tanks and barges to be

dedicated to that of food

stuffs.

FEDIOL code of working

practice for bulk road and tank

container transport of fats and

oils for direct food use (Ref

Check previous cargoes via

FEDIOL practical guide to

previous cargo(es) for means

of transport and tank lining

(Ref 07COD143F).

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07COD138).

- Tank coasters following EU

standards for the transport of

food stuffs

C Low High 3 Tank coasters carrying oils and fats

during short sea voyages in the EU

must have as an absolute minimum as

the immediate previous cargoes a

product that is either a foodstuff or a

product appearing on the EU list of

accepted immediate cargoes of

Directive 96/3/EC.

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (Ref

14COD152) (including

FOSFA operational

procedures).

Check previous cargoes via

FEDIOL practical guide to

previous cargo(es) for means

of transport and tank lining

(Ref 07COD143F). FOSFA

certificate of compliance,

cleanliness and suitability of

Ship’s tanks issued by a

FOSFA Member

Superintendent. FOSFA

combined Masters certificate

signed by the Captain/First

Officer or an equivalent

statement signed by the ship’s

owner or authorised agent,

applicable before any loading

or cargo transfer.

Contamination by cleaning

agents

- Tank cars, rail tanks and

barges

C Medium Medium 3 Increased risk at cleaning stations that

clean both feed and chemical tanks on

one site.

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (Ref

14COD152).

Apply good practices for

cleaning of tanks.

.

- Tank coasters C Medium Medium 3 Increased risk in case coaster is not

dedicated to feed- or foodstuff.

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (Ref

14COD152) (including

FOSFA operational

FOSFA certificate of

compliance, cleanliness and

suitability of Ship’s tanks

issued by a FOSFA Member

Superintendent.

FOSFA combined Masters

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procedures). certificate signed by the

Captain/First Officer or an

equivalent statement signed

by the ship’s owner or

authorised agent, applicable

before any loading or cargo

transfer.

Heating or cooling fluids

from equipment

- Tank cars C Low High 3 Stainless steel tanks are used which

are heated with cooling water from the

motor through a system of double walls

(and not coils).

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (14COD152).

Use of thermal heating fluids

in direct heating systems is

forbidden.

- Rail tanks, tank barges

- Tank coasters

C

C

Low

Low

High

High

3

3

Toxic thermal heating fluids may still be

used. However, due to the relatively

low heating temperatures applied

during transport, the chance of leakage

of thermal heating fluids into the

product is low.

Toxic thermal heating fluids may still be

used. However, due to the relatively

low heating temperatures applied

during transport, the chance of leakage

of thermal heating fluids into the

product is low.

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (14COD152).

FEDIOL Code of Practice for

the transport in bulk of oils

and fats into or within the

European Union (14COD152)

(including FOSFA operational

procedures).

Heating coils of rail tanks

must be of stainless steel .

If thermal heating fluids have

been used, the transporter of

the oil must provide for

documentation on possible

net losses and analyse

accordingly if necessary.

If thermal heating fluids have

been used, the transporter of

the oil must provide for

documentation on possible

net losses and analyse

accordingly if necessary.

The use of hot water or steam

heating is recommended.

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Foreign bodies P Medium Medium 3 A quality plan should require

the loading of tank cars with

refined oils under a roof.

Adulteration C/P/B Medium Medium 3 Adulteration with mineral oils has

happened with the transport of oils in

the countries of origin of these oils.

FEDIOL code of working

practice for bulk road and tank

container transport of fats and

oils for direct food use (Ref

07COD138)

Analyse all incoming batches.

Application of minimum

mandatory requirements of

FEDIOL code of working

practice for bulk road and tank

container transport of fats and

oils for direct food use such

as availability of whereabouts

of the truck during the journey

and sealing of the tank (Ref

07COD138).

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C. Storage of soybean oil

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY

STANDARDS AND/OR

CONTRACT TERMS

CONTROL MEASURE REMARKS

Contamination due to lack

of segregation

(contamination from previous

cargoes, use of incorrect

joining, shared equipment)

C Low High 3 This risk classification applies to terminals

that store both chemicals and vegetable

oils. Less risk is involved when the tank

terminal applies the EU list of acceptable

previous cargoes during sea transport to

the storage of vegetable oils. Least risk is

involved when the vegetable oils are

stored in tanks that are dedicated to the

storage of foodstuffs.

Terminals in the EU that store

oils and fats for food

application are obliged to

apply HACCP (EC Regulation

No. 852/2004)

Food or feed dedication of

storage tanks. Otherwise,

storage tanks must at least

adhere to the EU rules on

previous cargoes that have

been set up for sea transport

in Directive 96/3/EC.

Contamination by cleaning

agents

C Low High 3 This risk classification applies to terminals

that store both chemicals and vegetable

oils. They may abstain from using cleaning

agents that are suitable for use in the food

industry. For tank terminals in the EU that

apply HACCP and that keep the storage of

vegetable oils and chemicals separated,

the chance of using the wrong cleaning

agents is very low.

Cleaning agents must be

suitable for use in the food

industry.

Solvent from coating C Low High 3 Solvents from virgin coatings migrating to

the oil, which may end up in the fatty acid

distillates during refining

Use stainless steel tanks or in

case of use of tanks with

virgin coating, do not feed the

FAD

Thermal heating fluids from

failing equipment

C Low High 3 Toxic thermal heating fluids may still be

used. However, due to the relatively low

heating temperatures applied during

storage, the chance of leakage of thermal

heating fluids into the product is low.

If thermal heating fluids have

been used, the storage

company must provide for

documentation on net losses

and analyse accordingly, if

The use of water and

steam heating is

recommended.

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Feed Risk assessment of the chain of soya (bean) meal and oil products

necessary.

Misuse of additives C Low High 3 Additives allowed for food oil applied to oil

for feed –or vice versa- for which use they

may not have been approved.

Agree on clear specifications

as regards use of additives

Adulteration with mineral oil Low High 3 Adulteration with mineral oils has

happened in the countries of origin.

Control has been intensified and the

chance of adulteration taking place has

decreased.

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D. Transport of soybean oil by ocean going vessel

HAZARD CAT. CHANCE SERIOUSNESS RISK

CLASS. JUSTIFICATION

LEGISLATION, INDUSTRY STANDARDS

AND/OR CONTRACT TERMS CONTROL MEASURE REMARKS

Transport contamination

- Contamination by previous

cargoes present in tanks or

pipes

C Medium Medium 3 Ocean going vessels carrying oils and fats

for edible use into the EU must have as an

absolute minimum that the immediate

previous cargoes is a product that is either

a foodstuff or a product appearing on the

EU list of accepted immediate cargoes of

Directive 96/3/EC.

Directive 96/3/EC (Derogation to EC

Regulation No. 852/2004) requires that

previous loads have to be checked.

FOSFA contracts oblige the seller to

inform the buyer what the three

preceding cargoes have been during

the sea transport of oils and fats.

FEDIOL Code of Practice for the

transport in bulk of oils and fats into or

within the European Union (Ref

14COD152) (including FOSFA

operational procedures).

The EU has not regulated the sea

transport of oils and fats for feed

application.

FOSFA certificate of

compliance, cleanliness

and suitability of Ship’s

tanks issued by a FOSFA

Member Superintendent.

FOSFA combined Masters

certificate signed by the

Captain/First Officer or an

equivalent statement

signed by the ship’s owner

or authorised agent,

applicable before any

loading or cargo transfer

The use of dedicated pipe

lines at loading and

unloading.

- Contamination by cleaning

agents

C Low High 3 Usually maritime business sticks to good

practice.

Check ship log-book.

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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining

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Feed Risk assessment of the chain of soya (bean) meal and oil products

Solvent from coating C Low High 3 Solvents from virgin coatings migrating to

the oil, which may end up in the fatty acid

distillates during refining

Use stainless steel tanks

or in case of use of tanks

with virgin coating, do not

feed the FAD

Solvent from coating

Thermal heating fluids

(THF) from equipment

C Low High 3 Toxic thermal heating fluids may still be

used. However, due to the relatively low

heating temperatures applied during

transport, the chance of leakage of

thermal heating fluids into the product is

low.

FEDIOL Code of Practice for the

transport in bulk of oils and fats into or

within the European Union (including

FOSFA operational procedures).

If thermal heating fluids

have been used, the

transporter of the oil must

provide for documentation

on possible net losses and

analyse accordingly if

necessary.

The use of water and steam

heating is recommended.

Hydraulic oils from portable

pumps

C Low High 3 Hydraulic oils from portable pumps may

be toxic.

The use of portable pumps

with clear separation of

hydraulic motor from

pump. If not, hydraulic oils

of food grade quality must

be used.

Hydraulic motors that are

directly linked to the pump

allow for unwanted leakages

of hydraulic oil into the

vegetable oil in case of seal

failure.

Adulteration with mineral oil Low High 3 Adulteration with mineral oils has

happened in the countries of origin.

Control has been intensified and the

chance of adulteration taking place has

decreased.